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The DIGIPRIS is an online platform for the procedures and services of Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS). It was officially introduced by the COFEPRIS in the year 2020 and is a step towards the digitalization of pharmaceutical registrations in Mexico.

The DIGIPRIS consists of two (02) main interfaces:

  1. Self-managing processes: This includes fully digitalized solutions for digital submissions and resolutions. Changes that required multiple visits to the COFEPRIS can now be submitted and solved through this platform. This is done to clear the appointments requested daily and to help with the associated workload.
  2. Electronic submissions: This is the outset of a fully digitized system led by Regulatory precision. It eradicates the bureaucratic stages while focusing on legal and technical compliance. The first step of the electronic submissions is applicable for renewals, which are fully digitalized. The step is aligned with the latest renewal scheme published on May 31, 2021, per which the registrations must be renewed just once to be valid for a lifetime.

In the next few months, the DIGIPRIS will be expanding to carry out more than thirty (30) types of self-managed and electronic procedures for medicines and medical devices. It will also include cosmetics and food.

The DIGIPRIS is another landmark achievement for COFEPRIS. Mexico has dynamic Regulatory guidelines, and it is moving towards digitalization. Therefore, it is necessary to keep abreast with all the Regulatory amendments and advancements.

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